AccessGUDID - DEVICE: ProGen PRP Eclipse (00850060751103)

GUDID

Device Identifier (DI) Information

Brand Name: ProGen PRP Eclipse
Version or Model: P5PG019
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Bellus Medical, LLC

Primary DI Number: 00850060751103
Issuing Agency: GS1
Commercial Distribution End Date: December 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 005677967 *Terms of Use

Device Description: 15 mL Platelet Rich Plasma production device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61377	Autologous platelet-based product centrifuge tube	A small, cylindrical container intended to temporarily store venous blood and subsequently placed in a centrifuge to produce platelet rich fibrin (PRF) or platelet rich plasma (PRP) for application to the patient from whom the blood was taken (typically for mixing with bone graft to repair bone defects and/or application to skin wounds to accelerate healing and/or achieve haemostasis). It typically includes a lid intended to be pierced with a syringe needle for blood infusion and PRF/PRP withdrawal, clot activator (e.g., silica) and/or filter for isolation of the PRF/PRP, and a rotation mechanism facilitated by centrifugation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet And Plasma Separator For Bone Graft Handling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK170136	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b43ae46e-8ecb-4e1c-ae12-c900d3d77410
Public Version Date: December 12, 2024
Public Version Number: 3
DI Record Publish Date: August 28, 2024